Topics
- How to prevent 483 items related to data documentation
- The documentation practices that enhance study integrity, repeatability
- Why GLP serves as a good foundation for clinical studies, GMP, and even research
- The main documentation errors seen and cited by the FDA
- Tips for documentation in synthesis research and feasibility studies not regulated by GLP
- Tips for documentation in lab notebooks
- A brief historical review of poor documentatiuon in the past before the advent of GMP and GLP
- A test for confirming documentation is complete and accurate
Good Documentation Practices for GXPs 2012 brings together Management at sponsor companies, Study directors, Laboratory staff and analysts, Principal investigators and Contract laboratories.
